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    Summary
    EudraCT Number:2010-018411-15
    Sponsor's Protocol Code Number:28431754DIA3010
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-04-26
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2010-018411-15
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Compared With Placebo in the Treatment of Older Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Glucose Lowering Therapy
    A.4.1Sponsor's protocol code number28431754DIA3010
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCanagliflozin - capsule - 100 mg (eq. 100 mg base)
    D.3.2Product code JNJ-28431754
    D.3.4Pharmaceutical form Over encapsulated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCanagliflozin
    D.3.9.1CAS number 842133-18-0
    D.3.9.2Current sponsor codeJNJ-28431754
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCanagliflozin - capsule - 300 mg (eq. 300 mg base)
    D.3.2Product code JNJ-28431754
    D.3.4Pharmaceutical form Over encapsulated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcanagliflozin
    D.3.9.1CAS number 842133-18-0
    D.3.9.2Current sponsor codeJNJ-28431754
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 2 Diabetes Mellitus
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess the effect of the addition of treatment with canagliflozin relative to the addition of placebo on hemoglobin A1c (HbA1c) after 26 weeks of treatment
    • To assess the safety and tolerability of canagliflozin



    E.2.2Secondary objectives of the trial
    After 26 weeks of treatment, to assess the effect of canagliflozin relative to placebo on: Bone mineral density at the lumbar spine, hip, and distal forearm as measured by dual energy X-ray absorptiometry (DXA); Markers of bone turnover; Proportion of subjects achieving HbA1c <7.0% and <6.5%; Fasting plasma glucose; Body weight; Fasting plasma lipids ; Systolic and diastolic blood pressure; Time to rescue therapy and proportion of subjects receiving rescue therapy; Body composition as measured by DXA in a subset of subjects. After 52 weeks of treatment, to assess the effect of canagliflozin relative to placebo on: Bone mineral density at the lumbar spine, hip, and distal forearm as measured by DXA; Glycemic control; Proportion of subjects achieving HbA1c <7.0% and <6.5%; Body weight; Fasting plasma lipids; Systolic and diastolic blood pressure. After 104 weeks of treatment, please refer to section 2.1.2 of the protocol for complete description.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The substudy in part of the main study. Related to bone strength: The main outcome parameters for this substudy will be vertebral strength for the spine, and femoral strength. Other important strength parameters, stiffness and strength to density ratios will also be assessed. Refer to section 9.9 of the protocol.
    E.3Principal inclusion criteria
    • Man or woman > or=55 to < or =80 years of age at screening with T2DM; women must be at least 3 years postmenopausal
    • Has an HbA1c > or=7.0% to < or =10.0% at screening (or at Week -2, if HbA1c obtained more than 3 weeks prior to Week -2 visit), and
    – Not currently on AHA therapy (off for at least 12 weeks)
    or
    – On a stable regimen of AHA(s) in monotherapy or on combination therapy, with any approved class of agents (including metformin, SU, PPARgamma agent [ie, TZD], DPP-4 inhibitor, AGI, GLP-1 analogue, or insulin) used in accordance with local prescribing information, for at least 12 weeks prior to screening visit (and at least 6 months for subjects on a PPARgamma agent)
    Note: a stable dose of insulin is defined as no change in the insulin regimen (ie, type[s] of insulin) and < or =15% change in the average total daily dose of insulin (ie, average over 1 week to account for day to day variability, changes < or =15% over the preceding 12 weeks).
    • FPG <270 mg/dL (15 mmol/L) at Week -2.
    Note: at the investigator’s discretion, based upon review of recent SMBG values, subjects not meeting the Week -2 FPG criteria may return to the investigational site within 7 days for a 1-time repeat FPG and continue in the study if the subject’s repeat FPG meets the criterion.
    • Site fasting fingerstick glucose of > or =110 mg/dL (6.1 mmol/L) and <270 mg/dL (15 mmol/L) on Day 1.
    Note: at the investigator’s discretion, based upon review of recent SMBG values, subjects not meeting the Day 1 criteria may return to the investigational site within 7 days for a 1-time repeat fingerstick glucose and continue in the study if the subject’s repeat fingerstick glucose meets the criterion.
    • Adequate compliance with the run-in period study procedures, including performance of the SMBG measurements (completed at least 3 or more SMBG measurements per week) with appropriate diary entries, and ≥80% compliance (by pill count) with single-blind placebo capsules
    • Body mass index > or =20 to < or =40 kg/m2
    • Willing and able to adhere to the prohibitions and restrictions specified in this protocol
    • Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
    • To participate in the optional pharmacogenomic component of this study, subjects must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit). Refusal to give consent for this component does not exclude a subject from participation in the clinical study.
    E.4Principal exclusion criteria
    Diabetes-related or Metabolic
    • History of diabetic ketoacidosis, T1DM, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
    • Repeated FPG and/or fasting SMBG measurements > or =270 mg/dL (15 mmol/L) during the pretreatment phase, despite reinforcement of diet and exercise counseling
    • Have proliferative diabetic retinopathy for which treatment is planned during the course of the study
    • History of 1 or more severe hypoglycemic episode within 6 months before screening
    • History of hereditary glucose-galactose malabsorption or primary renal glucosuria
    • Ongoing, inadequately controlled thyroid disorder
    • Ongoing eating disorder or significant weight loss or weight gain within 12 weeks before the screening visit, defined as an increase or decrease of 5% in body weight based upon clinic-based measurement or, if not available, subject report
    Muscular/Skeletal
    • Use of a bisphosphonate within 12 months prior to screening or expected to receive treatment with bisphosphonate during the study period
    • If on medication treatment for osteoporosis (eg, estrogen replacement, selective estrogen receptor modulator [SERM] therapy, or calcitonin), not on a stable regimen (for at least 6 months prior to screening)
    • T score < -2.5 (at any site) in a subject not currently on treatment
    • Treatment with a corticosteroid medication within 3 months prior to screening (for more than a total of 14 days in duration) or likely to require treatment with a corticosteroid medication during the subject's participation in the study
    • Parathyroid hormone (teriparatide) treatment within 12 months prior to screening
    • Severe vitamin D deficiency with serum 25-hydroxy vitamin D level < or =10 ng/mL at screening or within 12 months prior to screening
    • Hypercalcemia
    • History of rheumatoid or other inflammatory arthritis
    • Conditions that interfere with accurate measurement of BMD
    • Non-healed fracture, or any fracture with 12 months of screening
    • Acquired or inherited bone disorders that may confound assessment of bone density or bone turnover or elevation of alkaline phosphatase >1.5xULN
    Renal/Cardiovascular
    • Renal disease that required treatment with immunosuppressive therapy or a history of dialysis or renal transplant.
    • Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident within 3 months before screening, or revascularization procedure is planned, or subject has a history of New York Heart Association (NYHA) Class III-IV cardiac disease (refer to Attachment 3, New York Heart Association Classification of Cardiac Disease, for a description of the classes).
    • Findings on 12-lead ECG that would require urgent diagnostic evaluation or intervention
    • Uncontrolled hypertension (ie, using an average of 3 seated blood pressure readings with a diastolic blood pressure > or =100 mmHg or systolic blood pressure > or =160 mmHg) at Week -2.
    Gastrointestinal
    • History of hepatitis B surface antigen or hepatitis C antibody positive (unless associated with documented persistently stable/normal range aspartate aminotransferase [AST] and ALT levels), or other clinically active liver disease.
    • History of prior bariatric surgical procedure within 3 years before the screening visit.
    Laboratory
    • Estimated glomerular filtration rate (eGFR) <50 mL/min/1.73 m2
    • For subjects taking metformin: serum creatinine > or =1.4 mg/dL (124 micromol/L) for men and > or =1.3 mg/dL (115 micromol/L) for women; no contraindication to the use of metformin (including eGFR) based upon the label of the country of the investigational site
    • Fasting serum triglycerides > or =600 mg/dL (6.74 mmol/L) at screening (or subsequent visit if not fasting at screening).
    • Alanine aminotransferase level >2.0 times the ULN or total bilirubin >1.5 times the ULN at screening
    Other conditions
    • History of malignancy within 5 years before screening
    • Clinically important hematologic disorder
    • History of positive human immunodeficiency virus (HIV) antibody
    • Investigator’s assessment that the subject’s life expectancy is less than 2 years
    • Any condition that in the opinion of the investigator would make participation not in the best interest of the subject, or could prevent, limit, or confound the protocol specified assessments
    Medications/Therapies
    • Current use of any other SGLT-2 inhibitor
    • Subjects receiving anti-hypertensive or anti-hyperlipidemic therapy not on a stable regimen (same medication and dose[s]) for at least 4 weeks before Day 1
    • Known allergies, hypersensitivity, or intolerance to canagliflozin or its excipients (refer to Section 14.1, Physical Description of Study Drugs)

    For a complete list, please refer to section 4.3 of the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the change in HbA1c from baseline to Week 26.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Pretreatment phase (screening and single-blind placebo run-in); then a double blind treatment phase
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial is the last visit of the last subject undergoing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 156
    F.4.2.2In the whole clinical trial 720
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard of care applies and there is no provision for providing study medication following study completion.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-16
    P. End of Trial
    P.End of Trial StatusOngoing
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